Caroline Hroncich

Industry experts weigh in on best practices, challenges, and mutual recognition of cleaning validation standards.

The landmark decision determined that biosimilar makers can notify manufacturers before receiving FDA approval.

FDA asked Endo Pharmaceuticals to remove Opana ER from the market, citing the potential for abuse.

Amgen filed a complaint against FDA claiming the agency unlawfully denied the company pediatric exclusivity for its secondary hyperparathyroidism treatment Sensipar.